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What it’s like to present a poster at Euro Convergence, with Raquel Carnero
Posted 08 July 2022 By Ryan Connors
Delegates submitted a record-breaking 20 posters for Euro Convergence 2022. Raquel Carnero’s submission, “Regulatory intelligence, to protect and to serve your medical device strategy in the world” took home the top prize.
Regulatory NewsRegulatory News
ICH details milestones reached on guidelines after Athens meeting
Posted 02 June 2022 By Joanne S. Eglovitch
The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for testing pharmaceuticals and extrapolating adult clin...
Feature ArticlesFeature Articles
April’s Regulatory Focus: Specialist vs. generalist, RI, and more
Posted 06 May 2022 By Renee Matthews
Feature articles during April examined the roles of the regulatory specialist and generalist and the application of regulatory intelligence (RI) in managing the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), developing an ...
Feature ArticlesFeature Articles
September’s Regulatory Focus: Diversity in regulatory affairs, clinical trials, and more
Posted 07 October 2021 By Renee Matthews
Feature articles during September focused on diversity in regulatory affairs, challenges in conducting medical device clinical trials in Europe, clinical trial regulation and laws in China, and risk management in working with third-party...
ReconRecon
Recon: FDA vax approval signals looming mandates; Pfizer's $2.3B Trillium takeover
Posted 23 August 2021 By Kari Oakes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: $26B Opioids lawsuit deal imminent; Amylyx closes $135M ALS financing deal
Posted 20 July 2021 By Kari Oakes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
EC issues first COVID therapeutics portfolio
Posted 29 June 2021 By Kari Oakes
“Today we are taking the first step towards a broad portfolio of therapeutics to treat COVID-19,” said Stella Kyriakides, EC’s Commissioner for Health and Food Safety. “Whilst vaccination is progressing at increasing speed, the virus wil...
Virtual Programs Virtual Programs
Business Writing for Regulatory Professionals: Making It Easy
Friday, 18 November 2022 (1:00 - 2:30PM) 1.5 RAC Credits Member: $175| Non-member: $200
Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise.
Virtual Programs Virtual Programs
Conflict Resolution and Negotiation: Effective Tools and Techniques (November2022)
Friday, 04 November 2022 (1:00 - 3:00PM) 2.0 RAC Credits Member: $230| Nonmember: $270 Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
Virtual Programs Virtual Programs
Preparing to Take the RAC Drugs Exam
Tuesday, 04 October 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 NonMembers: $1,150
Designed specifically for those preparing to take the RAC Drugs exam. This workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
Virtual Programs Virtual Programs
China NMPA Medical Device Regulations & NEW Revisions and Guidance
Monday, 07 November 2022 (8:00 - 12:00PM) 12.0 RAC Credits Member: $825 NonMember: $970
This interactive, three-day program will explore the fundamentals of Chinese NMPA regulations for medical devices, emphasizing updated revisions and guidance released within the last two years.
Online Course Online Course
An Essential Guide to Horizontal Role Change Thinking
Member: $95 Nonmember: $105
Sometimes the next step in one's career is not in the next-level role, but in something else. This tutorial will help you demonstrate that you can undertake a different role.
Online Course Online Course
An Essential Guide to Vertical Career Thinking
Member: $95 Nonmember: $105
This tutorial seeks to reframe one's thinking about expected performance. Providing insights which are typically absent or unclear from position descriptions.
Books Books
Introduction to the Due Diligence Process, Second Edition
Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
On-demand On-demand
Understanding and Applying FDA’s 510(k) Modifications Guidance
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it.
On-demand On-demand
A Roadmap for Driving Messages through Development, Submission and Beyond
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to build persuasive arguments that help smooth project management and regulatory strategy during development, submission and beyond.
On-demand On-demand
Argumentation and Persuasion for Regulatory Professionals
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to utilize structures to think through argumentation.
On-demand On-demand
Sponsored Webcast: eCTD Submission Challenges (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.
On-demand On-demand
Sponsored Webcast: FDA QMSR: What do the Proposed Changes Mean for Industry?
1.0 RAC Credits
Member: $0 | NonMember: $25
Speakers will review the history of quality systems, look at the changes to quality regulations and discuss the FDA’s intent to adopt the ISO 13485 standard.
     
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All Results

Virtual Programs Virtual Programs

Business Writing for Regulatory Professionals: Making It Easy

Friday, 18 November 2022 (1:00 - 2:30PM)
1.5RAC Credits
Member: $175| Non-member: $200
Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise.
Virtual Programs Virtual Programs

Conflict Resolution and Negotiation: Effective Tools and Techniques (November2022)

Friday, 04 November 2022 (1:00 - 3:00PM)
2.0RAC Credits
Member: $230| Nonmember: $270 Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
Online Course Online Course

An Essential Guide to Horizontal Role Change Thinking

Member: $95 Nonmember: $105
Sometimes the next step in one's career is not in the next-level role, but in something else. This tutorial will help you demonstrate that you can undertake a different role.
Online Course Online Course

An Essential Guide to Vertical Career Thinking

Member: $95 Nonmember: $105
This tutorial seeks to reframe one's thinking about expected performance. Providing insights which are typically absent or unclear from position descriptions.
Books Books

Introduction to the Due Diligence Process, Second Edition

Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
On-demand On-demand

Understanding and Applying FDA’s 510(k) Modifications Guidance

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it.
On-demand On-demand

A Roadmap for Driving Messages through Development, Submission and Beyond

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to build persuasive arguments that help smooth project management and regulatory strategy during development, submission and beyond.
On-demand On-demand

Argumentation and Persuasion for Regulatory Professionals

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to utilize structures to think through argumentation.
On-demand On-demand

Sponsored Webcast: eCTD Submission Challenges (On-Demand)

1.0RAC Credits
Members: $0 | Nonmembers: $25
Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.